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Monday, May 05, 2014

Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)

The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the ascension of the Gates Foundation new CEO, Dr Susan Desmond-Hellmann.(1-2)

Two Somewhat Redundant Lancet Articles

Dr Desmond-Hellmann trained as an oncologist, spent time working on AIDS and Kaposi's Sarcoma in Uganda, but then spent much of her career as a pharmaceutical/ biotechnology executive, as described in the first article,(1)

After returning from Uganda, Desmond-Hellmann joined the nascent Taxol
development programme at Bristol-Myers Squibb, before being poached by
Arthur Levinson, the then Head of Research and Development at Genentech.
Levinson was convinced Genentech had a strong pipeline of anticancer
therapies, and brought Desmond-Hellmann on board to help guide them
through to approval. The pipeline went stratospheric, and took
Desmond-Hellmann with it. By 2009 she had been promoted to President of
Product Development, having overseen the introduction of two of the
first gene-targeted therapies for cancer, bevacizumab and trastuzumab.

After Genentech was bought out by Roche, Dr Desmond-Hellmann became Chancellor of the University of California, San Francisco,

Over the next 5 years, Desmond-Hellmann instituted wide-ranging reforms
at UCSF, including aggressively cutting administrative waste and putting
a greater emphasis on partnerships with the biotech and pharmaceutical
sectors, coming in for some criticism in the process. 'Some of the press
suggested one of Sue's goals was to take UCSF out of the public
system', says [current UCSF interim Chancellor Sam] Hawgood. 'Nothing could be further form the truth. She was
very proud of the public mission of UCSF, and had no intent to alter
that.' Mindful of how damaging perceived conflicts of interest could
have been to her credibility during her time at UCSF, Desmond-Hellmann
says she 'specifically avoided being on pharma and biotech boards'.

The article suggested we should expect nothing but great things from Dr Desmond-Hellmann at the Gates Foundation,

it is Desmond-Hellmann's ability to forge partnerships and her wide
network of contacts, rather than her knack for cutting administrative
overheads, that will have seemed most attractive to the Gates Foundation
as it looks to speed up the process of translating research into
results.

The second article used remarkably similar wording(2), e.g., regarding her career in the pharmaceutical business,

Soon after joining the Taxol team, Desmond-Hellmann was leading it; the
kind of progress that was bound to catch the eye of Genentech's then
Head of Research and Development Arthur Levinson. What happened next is
part of pharmaceutical folklore, as Desmond-Hellmann helped to
mastermind one of the most profitable drug-development pipelines in
history, including the approval of two of the first targeted cancer
therapies, for Genentech.

Also, regarding her career at UCSF,(2)

Desmond-Hellmann from embarking on a programme of structural reforms to
cut administrative inefficiency and forge closer links with private
industry, something that still stirs up controversy. 'There definitely
were concerns, and there remain concerns in academia, about conflicts of
interest, privatisation. I think what helped most was that I was clear
in my actions that I did and do value that UCSF is a public institution,
and I think my actions spoke and speak for themselves', she says. But
Desmond-Hellmann is robust in her defence of the importance of
public—private partnerships for driving innovations that ultimately
benefit society.

Finally, regarding expectations for her performance in the future,

'There are a lot of people who are looking to the foundation, and in the
world of philanthropy there's a lot of visibility to the Bill &
Melinda Gates Foundation, so I certainly feel accountable and
responsible for doing a good job.' But, she asserts, 'I'm up for it'.
With a track record that ranges from clinical research, global health,
and the sharp end of commercial drug development, she seems to be made
for it.

So Lancet, a very well known journal which normally is very parsimonious about its use of the printed page, used two full pages for two very similar articles about the new Gates Foundation CEO. Both articles made the same points,
- Dr Desmond-Hellmann had a brilliant career in the pharmaceutical/ biotechnology business, and was responsible for the development of several important cancer drugs
- Dr Desmond-Hellmann made major reforms at UCSF, including pushing for some sort of privatization, and for public-private partnerships, while dismissing concerns about any resulting conflicts of interest
- Dr Desmond-Hellmann is likely to be very successful as Gates Foundation CEO.

What the Articles Did Not Say

When Dr Desmond-Hellmann's appointment as Chancellor of UCSF was announced in 2009, I suggested that she was a very unusual choice because of aspects of her track record in the pharmaceutical/ biotechnology business. Yet the Lancet's two articles on her prospects as new Gates Foundation CEO ignored these considerations, and ignored or downplayed aspects of her track record as UCSF Chancellor. In particular,

Defending $55,000/ Year Bevacizumab

As I noted in 2009, Dr Desmond-Hellmann's defense as a Genentech executive of the sky high prices the company was charging for its new drugs was well documented in an article in the Journal of the National Cancer Institute)(3)

And cancer biologics, though among the most costly drugs,
are still only a tiny fraction of total GDP, said Genentech's Susan
Desmond-Hellmann, president for product development, at AACR.

Hellmann
and others argue that with these drugs’ potential to alleviate the huge
societal burden of cancer, biologics are worth the cost.

The
industry has responded to concerns about costs by putting more
resources into patient assistance programs. When Genentech received U.S.
Food and Drug Administration approval for bevacizumab in lung cancer
last October, it also announced a cap on expenditures for the drug for
patients with family incomes less than $100,000 a year. In 2005, the
median household income was $46,326.

Originally announced as
$55,000, the cap actually doesn't kick in until after a patient has
received 10,000 mg. At the wholesale acquisition cost, 10,000 mg is
about $55,000, said Genentech spokesperson Edward Lang.

What
the companies have not done so far is reduce prices. The reason,
industry representatives say, is the need to recoup massive research and
development costs, including high manufacturing costs for biologics. These
costs have long kept biotech companies from making much of a profit
overall, Hellmann said. She noted that profit levels of publicly held
biotech firms have 'hovered close to zero' throughout the life of the
industry.

Whatever the company's nominal profit levels, its executives, including Dr Desmond-Hellmann, have made extremely good money. According to Genentech's 2008 proxy statement, (the last available, since the company has been bought out by Roche), Dr Desmond-Hellmann's total compensation was $8,361,348 in 2007 and $7,820,142 in 2006. In 2007, her total compensation was equal to 0.3% of the firm's total net income.

Of course, since 2007, and especially since 2009, the problem of hugely expensive pharmaceuticals as a driver of health care costs, especially in the US, has become all too apparent. The Lancet articles were completely silent about this aspect of Dr Desmond-Hellmann's track record, and what implications it might have for her new role of a foundation that spends $3 billion a year, mainly ostensibly to improve the health of poor people.

Since she began as Chancellor of UCSF in 2009, other aspects of Dr Desmond-Hellmann's track record came to light that might have a bearing on how she will conduct herself as Gates Foundation CEO.

Investments in Tobacco Stocks

As I posted in 2010, then NY Times reporter Duff Wilson discovered that Dr Desmond-Hellmann and her husband (also a physician), had stock holdings in Altria, the parent company of tobacco company Phillip Morris USA, worth between $100,000 and $1,000,000. When this made public, they abruptly sold the stock. The head of the UCSF tobacco control center then said, “I do find that kind of shocking, but at least she got rid of it,...”

The goals of tobacco companies seem completely antithetical to those of a medical school, especially one with a tobacco control center, and incidentally seem antithetical to those of the Gates Foundation, which has a tobacco control initiative, with a stated goal:

to reduce tobacco-related death and disease in developing countries by
preventing the initiation of new smokers, decreasing overall tobacco
use, and reducing exposure to secondhand smoke.

In 2011, I posted about Dr Desmond-Hellmann's vigorous push to create public-private partnerships, which seemed meant to turn UCSF into a de facto drug company research and development contract shop. At the time, I noted that many of her arguments seemed to be based on logical fallacies, and that she never provided any good evidence for her claims of marvelous new "innovations" that would result from such supposed partnerships. The Lancet articles did not mention any substantive concerns about this issue.

Dismissing Concerns about Conflicts of Interest

In 2012, I posted about how Dr Desmond-Hellmann also dismissed concerns that public-private partnerships could lead to damaging conflicts of interest, again employing several logical fallacies. In particular, she implied that medical academics should no longer just do research to advance knowledge, but had become responsible for getting their "discoveries to society," and therefore would have to "start a company or work with a company to commercialize a product." She did not seem to acknowledge the possibility that academics could make discoveries, but perhaps other people would be better at turning these discoveries into useful products. The Lancet articles were silent on these issues.

Minimizing Concerns about Conflicts of Interest due to Membership on the Board of Corporations with Health Care Agendas

As noted above, Dr Desmond-Hellmann stated that she demonstrated her sensitivity to the issue of conflicts of interest affecting academic health care by avoiding membership on boards of directors of "pharma or biotech" companies. These, of course are not the only sorts of for-profit corporations who have health care agendas. This statement appears to have been carefully worded to avoid dealing with Dr Desmond-Hellmann's membership since 2010 on the board of directors of Procter & Gamble (see the company's 2013 proxy statement.) While Procter & Gamble is no longer a major pharmaceutical company, it has a Global Health and Grooming unit, whose products include over the counter pharmaceuticals (e.g., Pepto-Bismal, Metamucil, Prilosec OTC). Also, while Procter & Gamble does not make it very obvious, it has also owned MDVIP, a company that employs physicians to provide concierge medical services, since 2010, although as Cincinnati.com just reported, it will soon sell this unit to private equity. So while perhaps Dr Desmond-Hellmann could claim that while she was UCSF Chancellor she was not on the board of directors of any pure pharmaceutical or biotechnology company, she was certainly on the board of a major international company that sells pharmaceuticals and other health care related products, and employs physicians to provide direct patient care. (Presumably, she will be staying on the P&G board while she is Gates Foundation CEO.) The Lancet did not mention this issue.

Privatizing UCSF

Also, the Lancet articles seemed to contradict other reports that Dr Desmond-Hellmann made a serious attempt to privatize at least some aspects of UCSF, but that this effort failed. (Note that quote by Dr Hawgood from the first article above.)

However, in 2012, I posted about a prevalent conspiracy theory that University of California managers were trying to take the university private. However, it seemed to be more of a theory, because at least one news report included statements that Dr Desmond-Hellmann wanted to take UCSF out of the state university system. This week, an article in the San Francisco Business Times suggested that this was a serious plan, in that Dr Desmond-Hellmann

The autonomy coming from the separation, Desmond-Hellmann argued at
the time, would have meant that the sole graduate-level-only campus in
the 10-campus UC system would no longer subsidize UC undergrad programs.
It also would have translated into UCSF having more control over
the money it generates from its medical center and other operations.

However, the same article noted that the current University of California President,

dismissed as 'loose talk' a more than two-year-old plan for UCSF to weaken its ties to the larger UC system. 'UCSF is firmly part of the system and will remain so,...'

The current president seemed to thus acknowledge that this plan existed, however "loose" it may have been. Clearly, the Lancet articles suggested rather that Dr Desmond-Hellmann did not have any privatization plans, whatever the criticisms people could have made of them.

Summary

We have often discussed the anechoic effect, how it seems taboo to discuss certain unpleasant facts and issues relevant to the health care system, especially those that might lead to questions about the abilities of the current leadership of large health care organizations. This taboo seems to particularly affect public discourse within the health care system, such as is found in medical and other scholarly health care journals.

The Lancet is one of the largest circulation and most prestigious medical journals. The Gates Foundation is one of the biggest foundations working in the health care sphere. In their latest letter, Bill and Melinda Gates stated,

Our foundation is teaming up with partners around the world to take on
some tough challenges: extreme poverty and poor health in developing
countries, and the failures of America’s education system.

Yet when the Lancet devoted two full pages to often repetitive discussion of the new leader of the Gates Foundation, it avoided discussion of several issues that might have lead to questions about whether her future leadership would really be about challenging "poor health in developing countries," rather than promoting the interests of large pharmaceutical/ biotechnology and other health care related companies, as she had apparently tried to do before. That such an important medical journal would publish such incomplete health news reporting suggests the operation of the anechoic effect.

I hope the questions that ought to be raised about Dr Desmond-Hellmann's priorities as CEO of the Gates Foundation will eventually be put to rest. It would be more reassuring, however, if they could be confronted directly rather than obfuscated. As long as big health care journals remain so deferential to big health care leaders, concerns we have raised before about whether health care is now primarily lead by a small in-group of executives and managers who may put private interests ahead of entrusted responsibilities remain acute.

As we have said many, many times, true health care reform would ensure that leaders of big health care organizations really put patients' and the public's health ahead of private interests.

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